DESCRIPTION (provided by applicant): The overall goal of this proposal is to facilitate Micah Berman's development into an established, independent cancer control investigator who focuses on the intersection of tobacco regulatory science and public health law. Prof. Berman is an attorney with considerable experience in tobacco policy and law; he has advised the U.S. Food and Drug Administration (FDA) on tobacco regulation, provided policy support to state and local tobacco control programs, and taught public health law. The proposed training plan will enable him to obtain training in public health sciences (including biology, epidemiology, health behavior, and environmental health sciences), risk sciences (including toxicology and risk assessment), and statistical analysis. Coursework will be split between in-person classes at Ohio State University (OSU) and online courses from the Risk Sciences and Public Policy Program at Johns Hopkins University. As a member of OSU's Comprehensive Cancer Center and with a joint faculty appointment in law and public health, Prof. Berman has an exceptionally supportive environment in which to undertake the planned training and research. Combined with his legal background, the training and research plan will enable him to engage in innovative transdisciplinary research that considers both the scientific and legal aspects of tobacco regulation. The proposed research will advance the science of tobacco regulation, thereby helping to reduce the incidence of tobacco-related cancer. Tobacco use is the leading preventable cause of cancer death in the U.S., responsible for approximately one in three cancer deaths. In 2009, Congress granted the FDA the authority to regulate tobacco products, including the ability to conduct pre-market review of new products, evaluate health-related claims made by manufacturers, and set standards relating to a product's composition or characteristics. These new regulatory tools represent a tremendous opportunity to reduce tobacco-related death and disease. In implementing this new authority, the FDA must be able to synthesize information from a wide range of scientific disciplines-from toxicology to epidemiology-and make informed predictions about the likely effects of regulatory judgments. Thus, new methods are needed for conducting weight-of-scientific-evidence (WOSE) reviews and risk assessments in the context of tobacco regulation. Additionally, because tobacco regulations are likely to be challenged in court, any framework for tobacco product assessment must incorporate the standards that courts will use when reviewing the adequacy of the scientific evidence. The overall objective of this proposed research plan is to develop a comprehensive framework for the assessment of tobacco products that fuses scientific and legal considerations and includes novel risk assessment methodologies. This research builds upon the work of the NCI-funded Tobacco Product Assessment Consortium (TobP...